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510(k) K233122

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) by Litu Tech , Ltd. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2024
Date Received
September 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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